a. Hematological i. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ii. Platelet count (Plt) ≥ 100 x 109/L iii. Hemoglobin (Hb) ≥ 9 g/dL iv. International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤ 3 for subjects receiving anticoagulant therapy such as Coumadin or heparin b. Renal i. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels > 1.5 x institutional ULN c. Hepatic i. Total bilirubin ≤ 1.5 x ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5 x ULN for subjects with known liver metastases d. Metabolic i. Glycated hemoglobin (HbA1c) ≤ 8%